Clearance Summary
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 received FDA 510(k) clearance under submission number K082655, sponsored by Envitec-Wismar GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2008-11-25.
- Submission: K082655
- Applicant / Sponsor: Envitec-Wismar GmbH
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 2008-11-25
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.